Articles

FUJIFILM Diosynth Biotechnologies plans to invest £400 million (US$528 million) to expand its Billingham, Teeside facility in the United Kingdom.

FUJIFILM Diosynth Biotechnologies to Create Major Biopharma Manufacturing Site in United Kingdom

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

General agreement that FDA needs a confirmed commissioner may speed Califf’s appointment.

Califf Gains Bipartisan Support for FDA Confirmation

The European Medicines Agency has accepted Sanofi’s marketing authorization application for olipudase alfa, a potential new therapy for acid sphingomyelinase deficiency, a rare disease.

EMA Accepts MAA for Sanofi’s Rare Disease Therapy

FDA approved American Regent’s Injectafer (ferric carboxymaltose injection) for the treatment of pediatric patients with iron deficiency anemia.

FDA Approves American Regent’s Injectafer for Pediatric Patients

Pfizer’s $6.7 billion acquisition of Arena will give them access to a portfolio of immuno-inflammatory therapies.

Pfizer Acquires Arena Pharmaceuticals for $6.7 Billion

GlaxoSmithKline, together with the University of Oxford, has launched the Oxford-GSK Institute under a new collaboration that aims to study complex diseases to accelerate the success of drug discovery and drug development efforts.

GSK and University of Oxford Partner on Disease Research to Advance Drug Discovery and Development

GlaxoSmithKline and Vir Biotechnology have received a conditional marketing authorization from MHRA for Xevudy (sotrovimab) in the treatment of COVID-19.

GSK and Vir Biotechnology’s Xevudy Gets Conditional Marketing Authorization from MHRA for COVID-19 Treatment

Aizon Unify is designed to provide a digital platform for biopharmaceutical data monitoring, analysis, and optimization.

Aizon Launches a New GxP Compliant Data Aggregation Solution

Fareva plans to use blow-fill-seal equipment and ApiJect’s prefilled injector technology to create fill/finish capacity in France.

Fareva and ApiJect Plan Vaccine Packaging Capacity in France 

Guide addresses challenges of applying GMPs to autologous cell therapy manufacturing.

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